[Remote] Senior Clinical Database Programmer - eCOA

Note: The job is a remote job and is open to candidates in USA. Parexel is hiring a Senior Clinical Database Programmer - eCOA to design, configure, test, deploy, and maintain eCOA solutions for clinical trials. The role translates protocols and instrument requirements into compliant study workflows, supports eCOA-to-EDC integration, and collaborates with sponsors and cross-functional teams through study closeout.

Responsibilities

• Design, set up, maintain, revise, and close out eCOA studies by interpreting protocols, schedules of assessments, eCOA specifications, and licensed instrument requirements
• Configure questionnaires, screens, field properties, code lists, schedules, branching logic, rules, reminders, alerts, notifications, and study settings in the approved eCOA platform, applying established naming conventions and build standards
• Coordinate the initial eCOA configuration and controlled push to EDC, maintaining alignment among the eCOA configuration, EDC draft, and applicable CRF versions
• Assess and implement approved protocol amendments, production revisions, translations, and study maintenance changes while protecting data integrity and traceability
• Perform technical quality control of eCOA configurations against approved specifications and support User Acceptance Testing (UAT), including test evidence, defect triage, and resolution
• Coordinate deployment readiness and support post-production troubleshooting and controlled implementation of approved corrections
• Collaborate with Clinical Database Programming, Data Management, eCOA Clinical Data Analysis, COA Science, and Clinical Operations to finalize eCOA requirements and resolve design issues
• Lead or participate in design and build meetings, communicate configuration status, identify risks and dependencies, and manage scope, timeline, and resourcing changes across multiple projects
• Serve as a technical contact for sponsors and vendors on eCOA design, specification, testing, and deployment topics, as assigned
• Create and maintain eCOA specifications, configuration records, test evidence, and other study artifacts in accordance with SOPs, Work Instructions, ICH-GCP, and applicable regulatory requirements
• Provide role-relevant training, coaching, and technical guidance to project teams and less-experienced study designers, and contribute to standards, reusable libraries, and continuous improvement

Skills

• Strengths in questionnaire design, eCOA study configuration, and technical quality control
• Experience working in clinical research, healthcare, or a regulated environment
• The ability to collaborate across global, cross-functional teams and communicate technical design decisions clearly to technical and non-technical audiences
• A patient-focused mindset and strong attention to detail
• Comfort working with eCOA platforms such as Medidata Designer eCOA, EDC systems such as Medidata Rave, and validated clinical systems
• Bachelor's degree in life sciences, computer science, health informatics, clinical research, or a related discipline
• Proven experience with eCOA, ePRO, or eDiary
• Strong clinical research industry experience within a CRO or pharmaceutical setting
• Experience with EDC systems and an understanding of eCOA-to-EDC configuration dependencies and data flow
• Knowledge of questionnaire design, schedules, branching logic, reminders, notifications, translations, version management, and participant workflows
• Knowledge of SOPs, Work Instructions, system life-cycle methodologies, ICH-GCP, 21 CFR Part 11, and other applicable local and international regulatory requirements
• Experience with technical quality control, UAT, defect management, change control, and validated clinical systems
• Experience supporting global studies, sponsors, and cross-functional project teams
• Strong communication, organization, and problem-solving skills, including root-cause analysis, risk identification, and decision-making in ambiguous situations
• Proficient presentation and system-demonstration skills
• Written and oral fluency in English
• Hands-on experience configuring an eCOA platform such as Medidata Designer eCOA, or comparable study-design technology
• Experience with Medidata Rave EDC

Benefits

• Health, Vision & Dental Insurance
• Tuition Reimbursement
• Vacation/Holiday/Sick Time
• Flexible Spending & Health Savings Accounts
• Work/Life Balance
• 401(k) with Company match
• Pet Insurance
• Paid time off
• Life insurance

Company Overview

Company H1B Sponsorship